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Trial record 31 of 47 for:    DESIPRAMINE

Naltrexone & SSRI in Alcoholics With Depression/PTSD

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ClinicalTrials.gov Identifier: NCT00338962
Recruitment Status : Completed
First Posted : June 20, 2006
Results First Posted : February 5, 2016
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Alcoholism
Depression
PTSD
Interventions Drug: paroxetine
Drug: desipramine
Drug: Naltrexone
Drug: Placebo
Enrollment 88
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paroxetine and Naltrexone Paroxetine and Placebo Desipramine and Naltrexone Desipramine and Placebo
Hide Arm/Group Description

Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.

paroxetine: paroxetine (40mg/day)

Naltrexone: 50 mg per day

Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.

paroxetine: paroxetine (40mg/day)

Placebo: placebo

Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.

desipramine: 200 mg per day

Naltrexone: 50 mg per day

Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.

desipramine: 200 mg per day

Placebo: placebo

Period Title: Overall Study
Started 22 20 22 24
Completed 14 16 16 21
Not Completed 8 4 6 3
Reason Not Completed
Lost to Follow-up             3             3             2             3
Withdrawal by Subject             1             0             0             0
No Transportation             2             0             0             0
Time Constraint             2             0             0             0
Moved             0             1             0             0
Adverse Event             0             0             2             0
Poor Compliance             0             0             2             0
Arm/Group Title Paroxetine and Naltrexone Paroxetine and Placebo Desipramine and Naltrexone Desipramine and Placebo Total
Hide Arm/Group Description

Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.

paroxetine: paroxetine (40mg/day)

Naltrexone: 50 mg per day

Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.

paroxetine: paroxetine (40mg/day)

Placebo: placebo

Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.

desipramine: 200 mg per day

Naltrexone: 50 mg per day

Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.

desipramine: 200 mg per day

Placebo: placebo

Total of all reporting groups
Overall Number of Baseline Participants 22 20 22 24 88
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 20 participants 22 participants 24 participants 88 participants
45.14  (6.71) 49.15  (8.95) 47.05  (9.96) 47.04  (9.72) 47.1  (8.90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 20 participants 22 participants 24 participants 88 participants
Female
0
   0.0%
1
   5.0%
4
  18.2%
3
  12.5%
8
   9.1%
Male
22
 100.0%
19
  95.0%
18
  81.8%
21
  87.5%
80
  90.9%
1.Primary Outcome
Title Mean Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)
Hide Description The OCDS is a 14-item (rated 0-4), self-administered questionnaire for characterizing and quantifying the obsessive and compulsive cognitive aspects of craving and heavy (alcoholic) drinking, such as drinking-related thought, urges to drink, and the ability to resist those thoughts and urges. A higher total score indicates higher craving and ranges from 0-48.
Time Frame beginning of treatment (week 1), and end of treatment (13 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paroxetine and Naltrexone Paroxetine and Placebo Desipramine and Naltrexone Desipramine and Placebo
Hide Arm/Group Description:

Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.

paroxetine: paroxetine (40mg/day)

Naltrexone: 50 mg per day

Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.

paroxetine: paroxetine (40mg/day)

Placebo: placebo

Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.

desipramine: 200 mg per day

Naltrexone: 50 mg per day

Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.

desipramine: 200 mg per day

Placebo: placebo

Overall Number of Participants Analyzed 14 16 16 21
Mean (Standard Error)
Unit of Measure: units on a scale
Week 1 21.273  (2.547) 20.700  (2.672) 18.500  (2.547) 21.458  (2.439)
Week 13 10.013  (3.009) 9.690  (3.025) 4.296  (2.847) 7.489  (2.483)
2.Primary Outcome
Title Clinician-Administered PTSD Scale (CAPS)
Hide Description

The CAPS is the gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to:

Make current (past month) diagnosis of PTSD Make lifetime diagnosis of PTSD Assess PTSD symptoms over the past week Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). A higher score is associated with higher severity of PTSD. The score is interpreted as follows: 0-19=Asymptomatic/few symptoms 20-39=Sub-threshold/mild PTSD 40-59=Threshold PTSD/moderate 60-79=Severe PTSD >80=Extreme PTSD

Time Frame beginning of treatment (week 1), and end of treatment (13 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paroxetine and Naltrexone Paroxetine and Placebo Desipramine and Naltrexone Desipramine and Placebo
Hide Arm/Group Description:

Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.

paroxetine: paroxetine (40mg/day)

Naltrexone: 50 mg per day

Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.

paroxetine: paroxetine (40mg/day)

Placebo: placebo

Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.

desipramine: 200 mg per day

Naltrexone: 50 mg per day

Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.

desipramine: 200 mg per day

Placebo: placebo

Overall Number of Participants Analyzed 14 16 16 21
Mean (Standard Error)
Unit of Measure: units on a scale
Beginning of Treatment 73.54  (5.007) 69.810  (5.166) 62.500  (5.047) 77.833  (4.832)
End of Treatment 40.024  (5.53) 36.591  (5.570) 26.751  (5.353) 41.392  (4.949)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paroxetine and Naltrexone, Paroxetine and Placebo, Desipramine and Naltrexone, Desipramine and Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00
Comments Bonferonni adjustments were applied. Mixed effects models were used to assess changes in PTSD symptoms over time.
Method Mixed Models Analysis
Comments F=49.633
3.Primary Outcome
Title Hamilton Depression Rating Scale (HAM-D)
Hide Description The HAM-D ranges from 0 (Normal) to >23 (Very Severe Depression)
Time Frame beginning of treatment (week 1), and end of treatment (13 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paroxetine and Naltrexone Paroxetine and Placebo Desipramine and Naltrexone Desipramine and Placebo
Hide Arm/Group Description:

Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.

paroxetine: paroxetine (40mg/day)

Naltrexone: 50 mg per day

Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.

paroxetine: paroxetine (40mg/day)

Placebo: placebo

Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.

desipramine: 200 mg per day

Naltrexone: 50 mg per day

Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.

desipramine: 200 mg per day

Placebo: placebo

Overall Number of Participants Analyzed 14 16 16 21
Mean (Standard Error)
Unit of Measure: units on a scale
Beginning of Treatment 13.273  (1.112) 10.950  (1.167) 11.195  (1.132) 13.167  (1.065)
End of Treatment 9.328  (1.256) 8.238  (1.299) 8.563  (1.201) 8.943  (1.117)
4.Primary Outcome
Title Mean Number of Side Effects
Hide Description Differences in mean number of side effects reported for each group. Side effects and common adverse symptoms were evaluated by the research staff weekly, using a modified version of the ystematic Assessment for Treatment Emergent Events. The symptoms that are known to be associated with treatment with desipramine, paroxetine, and naltrexone were specifically screened or on a weekly basis. The symptoms were then clustered into the following categories: gastrointestinal, emotional, cold and flu symptoms, skin, sexual, neurological, and cardiac.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paroxetine and Naltrexone Paroxetine and Placebo Desipramine and Naltrexone Desipramine and Placebo
Hide Arm/Group Description:

Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.

paroxetine: paroxetine (40mg/day)

Naltrexone: 50 mg per day

Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.

paroxetine: paroxetine (40mg/day)

Placebo: placebo

Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.

desipramine: 200 mg per day

Naltrexone: 50 mg per day

Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.

desipramine: 200 mg per day

Placebo: placebo

Overall Number of Participants Analyzed 22 20 22 24
Mean (Standard Error)
Unit of Measure: side effects
Gastrointestinal symptoms 3.651  (.487) 2.688  (.513) 3.052  (.475) 3.653  (.431)
Emotional Symptoms 4.874  (.686) 3.963  (.719) 3.727  (.689) 5.248  (.629)
Neurological Symptoms 6.212  (1.058) 5.078  (1.106) 4.201  (1.047) 4.566  (.970)
Cold Symptoms 2.182  (.490) 2.393  (.512) 1.891  (.483) 2.253  (.447)
Skin Symptoms 1.002  (.240) .859  (.252) .591  (.236) 1.057  (.215)
Sexual Symptoms .877  (.241) .932  (.252) .737  (.238) .736  (.219)
Cardiac Symptoms .416  (.093) .474  (.101) .389  (.089) .356  (.076)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paroxetine and Naltrexone, Paroxetine and Placebo, Desipramine and Naltrexone, Desipramine and Placebo
Comments Gastrointestinal symptoms compared
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame 9 weeks afters study medication
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paroxetine and Naltrexone Paroxetine and Placebo Desipramine and Naltrexone Desipramine and Placebo
Hide Arm/Group Description

Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.

paroxetine: paroxetine (40mg/day)

Naltrexone: 50 mg per day

Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.

paroxetine: paroxetine (40mg/day)

Placebo: placebo

Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.

desipramine: 200 mg per day

Naltrexone: 50 mg per day

Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.

desipramine: 200 mg per day

Placebo: placebo

All-Cause Mortality
Paroxetine and Naltrexone Paroxetine and Placebo Desipramine and Naltrexone Desipramine and Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Paroxetine and Naltrexone Paroxetine and Placebo Desipramine and Naltrexone Desipramine and Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/22 (4.55%)      2/20 (10.00%)      0/22 (0.00%)      0/24 (0.00%)    
Injury, poisoning and procedural complications         
Death  [1]  1/22 (4.55%)  1 0/20 (0.00%)  0 0/22 (0.00%)  0 0/24 (0.00%)  0
Nervous system disorders         
Seizure   0/22 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  0/24 (0.00%) 
Psychiatric disorders         
Hospitalized for severe anxiety   0/22 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  0/24 (0.00%) 
Indicates events were collected by systematic assessment
[1]
Subject was injured at work. Death was not study related.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Paroxetine and Naltrexone Paroxetine and Placebo Desipramine and Naltrexone Desipramine and Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/22 (4.55%)      1/20 (5.00%)      2/22 (9.09%)      2/24 (8.33%)    
Cardiac disorders         
Tachycardia   0/22 (0.00%)  0/20 (0.00%)  0/22 (0.00%)  1/24 (4.17%) 
General disorders         
Incarcerated for intoxication   1/22 (4.55%)  0/20 (0.00%)  0/22 (0.00%)  1/24 (4.17%) 
Nervous system disorders         
Dizziness and Lightheadedness   0/22 (0.00%)  0/20 (0.00%)  2/22 (9.09%)  0/24 (0.00%) 
Psychiatric disorders         
Suicidal Ideation  [1]  0/22 (0.00%)  1/20 (5.00%)  0/22 (0.00%)  0/24 (0.00%) 
Indicates events were collected by systematic assessment
[1]
9 weeks after discontinuing meds
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Elizabeth Ralevski
Organization: Yale University
Phone: 203-932-5711 ext 4282
EMail: elizabeth.ralevski@yale.edu
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00338962     History of Changes
Other Study ID Numbers: HIC # 11637
First Submitted: June 15, 2006
First Posted: June 20, 2006
Results First Submitted: November 4, 2015
Results First Posted: February 5, 2016
Last Update Posted: February 5, 2016